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A recent medical device user fee negotiation meeting sees CDRH proposing numerous program enhancements to improve consistency and ...[ Price : $8.95]
Hyman, Phelps & McNamara asks FDA to reverse a recent guidance limiting the way drug sponsors can appeal FDA decisions they believ...[ Price : $8.95]
FDAs New York District Office warns Medisca about mislabeled APIs intended for use by compounding pharmacies and other violations....[ Price : $8.95]
Public Citizen blasts a 21st Century Cures provision to reward companies with longer patent periods and higher prices for branded ...[ Price : $8.95]
FDA releases minutes describing progress made during discussions with industry at three PDUFA 6 steering committee meetings and on...[ Price : $8.95]
FDA clears a Dignitana de novo petition to allow marketing of the DigniCap Cooling System, a cooling cap designed to reduce hair l...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Applied Nutriceuticals, DBM Nutrition, ICF International, Medisca Pharmaceutique...[ Price : $8.95]
Pfizer says it has awarded five grants totaling more than $4 million under its inaugural Advancing Science through Pfizer Investig...